Not Cleared Direct

DEN140038 - Dexcom Share Direct Secondary Displays (FDA 510(k) Clearance)

Class II Chemistry device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN140038 · Dexcom, Inc. · Chemistry device
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Jan 2015
Decision
39d
Days
Class 2
Risk

DEN140038 is an FDA 510(k) submission (not cleared) for the Dexcom Share Direct Secondary Displays. Classified as Continuous Glucose Monitor Secondary Display (product code PJT), Class II - Special Controls.

Submitted by Dexcom, Inc. (San Diego, US). The FDA issued a Not Cleared (DENG) decision on January 23, 2015 after a review of 39 days.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1350 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Chemistry review framework.

View all Dexcom, Inc. devices

Submission Details

510(k) Number DEN140038 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received December 15, 2014
Decision Date January 23, 2015
Days to Decision 39 days
Submission Type Direct
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 88d · This submission: 39d
Pathway characteristics

Device Classification

Product Code PJT Continuous Glucose Monitor Secondary Display
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1350
Definition The Purpose Of The Continuous Glucose Monitor Secondary Display Is To Notify Another Person, The Follower, Of The Patient's Continuous Glucose Monitoring System Sensor Glucose Information In Real Time. The Secondary Display Is Intended For Providing Secondary Notification Of A Continuous Glucose Monitoring System And Does Not Replace Primary Real Time Continuous Glucose Monitoring Or Standard Home Blood Glucose Monitoring
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.